Correlation of Stomatitis and Cutaneous Toxicity With Clinical Outcome in Patients With Metastatic Renal-Cell Carcinoma Treated With Everolimus

Vincenza Conteduca, Matteo Santoni, Matelda Medri, Emanuela Scarpi, Luciano Burattini, Cristian Lolli, Lorena Rossi, Agnese Savini, Rossana Berardi, Ignazio Stanganelli, Stefano Cascinu, Ugo De Giorgi

Research output: Contribution to journalArticle

7 Citations (Scopus)

Abstract

Background: In clinical practice, discontinuation or dose reduction of everolimus may be induced not only by grade 3 or 4 toxicities but also by prolonged grade 2 toxicities, such as stomatitis and/or cutaneous toxicity, which share some pathogenetic mechanisms. We assessed the correlation between either everolimus discontinuation or dose reduction induced by stomatitis-cutaneous toxicity events (SCTE) and clinical outcome of patients with metastatic renal-cell cancer (mRCC). Patients and Methods: We retrospectively reviewed the clinical data of patients with mRCC treated with everolimus in 2 Italian centers. Clinical evidence of SCTE was evaluated, and corresponding clinical data were reviewed for response and clinical outcome. Results: Seventy-nine mRCC patients treated with everolimus (57 male, 22 female; median age 66 years; range, 44-88 years) were evaluated. SCTE were observed in 20 (25%) of 79 patients at a median of 30.5 days of everolimus treatment (range, 10-270 days). Partial response or stable disease was achieved in 15 (79%) of 19 evaluable patients with SCTE compared to 28 (48%) of 58 with no SCTE (P = .03). At a median follow-up of 19 months, a significant difference was found in the median PFS equal to 7.8 months (95% confidence interval [CI], 2.8-24.4) in SCTE patients versus 4.3 months (95% CI, 2.7-7.5) in non-SCTE patients (P = .029), and in the median OS equal to 30.6 months (95% CI, 19.6-not reached) in SCTE patients versus 13.5 months (95% CI, 9.9-17.7) in non-SCTE patients (P = .0007). Conclusion: These data suggest that SCTE may be a predictive marker of favorable outcome in mRCC patients treated with everolimus.

Original languageEnglish
JournalClinical Genitourinary Cancer
DOIs
Publication statusAccepted/In press - Nov 5 2015

Fingerprint

Stomatitis
Renal Cell Carcinoma
Skin
Confidence Intervals
Everolimus

Keywords

  • Dose reduction
  • Metastatic renal-cell cancer
  • Predictive marker
  • Skin toxicities
  • Survival

ASJC Scopus subject areas

  • Oncology
  • Urology

Cite this

Correlation of Stomatitis and Cutaneous Toxicity With Clinical Outcome in Patients With Metastatic Renal-Cell Carcinoma Treated With Everolimus. / Conteduca, Vincenza; Santoni, Matteo; Medri, Matelda; Scarpi, Emanuela; Burattini, Luciano; Lolli, Cristian; Rossi, Lorena; Savini, Agnese; Berardi, Rossana; Stanganelli, Ignazio; Cascinu, Stefano; De Giorgi, Ugo.

In: Clinical Genitourinary Cancer, 05.11.2015.

Research output: Contribution to journalArticle

Conteduca, Vincenza ; Santoni, Matteo ; Medri, Matelda ; Scarpi, Emanuela ; Burattini, Luciano ; Lolli, Cristian ; Rossi, Lorena ; Savini, Agnese ; Berardi, Rossana ; Stanganelli, Ignazio ; Cascinu, Stefano ; De Giorgi, Ugo. / Correlation of Stomatitis and Cutaneous Toxicity With Clinical Outcome in Patients With Metastatic Renal-Cell Carcinoma Treated With Everolimus. In: Clinical Genitourinary Cancer. 2015.
@article{d2e0a8bac2ff48ba99e8d4074bc49b66,
title = "Correlation of Stomatitis and Cutaneous Toxicity With Clinical Outcome in Patients With Metastatic Renal-Cell Carcinoma Treated With Everolimus",
abstract = "Background: In clinical practice, discontinuation or dose reduction of everolimus may be induced not only by grade 3 or 4 toxicities but also by prolonged grade 2 toxicities, such as stomatitis and/or cutaneous toxicity, which share some pathogenetic mechanisms. We assessed the correlation between either everolimus discontinuation or dose reduction induced by stomatitis-cutaneous toxicity events (SCTE) and clinical outcome of patients with metastatic renal-cell cancer (mRCC). Patients and Methods: We retrospectively reviewed the clinical data of patients with mRCC treated with everolimus in 2 Italian centers. Clinical evidence of SCTE was evaluated, and corresponding clinical data were reviewed for response and clinical outcome. Results: Seventy-nine mRCC patients treated with everolimus (57 male, 22 female; median age 66 years; range, 44-88 years) were evaluated. SCTE were observed in 20 (25{\%}) of 79 patients at a median of 30.5 days of everolimus treatment (range, 10-270 days). Partial response or stable disease was achieved in 15 (79{\%}) of 19 evaluable patients with SCTE compared to 28 (48{\%}) of 58 with no SCTE (P = .03). At a median follow-up of 19 months, a significant difference was found in the median PFS equal to 7.8 months (95{\%} confidence interval [CI], 2.8-24.4) in SCTE patients versus 4.3 months (95{\%} CI, 2.7-7.5) in non-SCTE patients (P = .029), and in the median OS equal to 30.6 months (95{\%} CI, 19.6-not reached) in SCTE patients versus 13.5 months (95{\%} CI, 9.9-17.7) in non-SCTE patients (P = .0007). Conclusion: These data suggest that SCTE may be a predictive marker of favorable outcome in mRCC patients treated with everolimus.",
keywords = "Dose reduction, Metastatic renal-cell cancer, Predictive marker, Skin toxicities, Survival",
author = "Vincenza Conteduca and Matteo Santoni and Matelda Medri and Emanuela Scarpi and Luciano Burattini and Cristian Lolli and Lorena Rossi and Agnese Savini and Rossana Berardi and Ignazio Stanganelli and Stefano Cascinu and {De Giorgi}, Ugo",
year = "2015",
month = "11",
day = "5",
doi = "10.1016/j.clgc.2016.02.012",
language = "English",
journal = "Clinical Genitourinary Cancer",
issn = "1558-7673",
publisher = "Elsevier Inc.",

}

TY - JOUR

T1 - Correlation of Stomatitis and Cutaneous Toxicity With Clinical Outcome in Patients With Metastatic Renal-Cell Carcinoma Treated With Everolimus

AU - Conteduca, Vincenza

AU - Santoni, Matteo

AU - Medri, Matelda

AU - Scarpi, Emanuela

AU - Burattini, Luciano

AU - Lolli, Cristian

AU - Rossi, Lorena

AU - Savini, Agnese

AU - Berardi, Rossana

AU - Stanganelli, Ignazio

AU - Cascinu, Stefano

AU - De Giorgi, Ugo

PY - 2015/11/5

Y1 - 2015/11/5

N2 - Background: In clinical practice, discontinuation or dose reduction of everolimus may be induced not only by grade 3 or 4 toxicities but also by prolonged grade 2 toxicities, such as stomatitis and/or cutaneous toxicity, which share some pathogenetic mechanisms. We assessed the correlation between either everolimus discontinuation or dose reduction induced by stomatitis-cutaneous toxicity events (SCTE) and clinical outcome of patients with metastatic renal-cell cancer (mRCC). Patients and Methods: We retrospectively reviewed the clinical data of patients with mRCC treated with everolimus in 2 Italian centers. Clinical evidence of SCTE was evaluated, and corresponding clinical data were reviewed for response and clinical outcome. Results: Seventy-nine mRCC patients treated with everolimus (57 male, 22 female; median age 66 years; range, 44-88 years) were evaluated. SCTE were observed in 20 (25%) of 79 patients at a median of 30.5 days of everolimus treatment (range, 10-270 days). Partial response or stable disease was achieved in 15 (79%) of 19 evaluable patients with SCTE compared to 28 (48%) of 58 with no SCTE (P = .03). At a median follow-up of 19 months, a significant difference was found in the median PFS equal to 7.8 months (95% confidence interval [CI], 2.8-24.4) in SCTE patients versus 4.3 months (95% CI, 2.7-7.5) in non-SCTE patients (P = .029), and in the median OS equal to 30.6 months (95% CI, 19.6-not reached) in SCTE patients versus 13.5 months (95% CI, 9.9-17.7) in non-SCTE patients (P = .0007). Conclusion: These data suggest that SCTE may be a predictive marker of favorable outcome in mRCC patients treated with everolimus.

AB - Background: In clinical practice, discontinuation or dose reduction of everolimus may be induced not only by grade 3 or 4 toxicities but also by prolonged grade 2 toxicities, such as stomatitis and/or cutaneous toxicity, which share some pathogenetic mechanisms. We assessed the correlation between either everolimus discontinuation or dose reduction induced by stomatitis-cutaneous toxicity events (SCTE) and clinical outcome of patients with metastatic renal-cell cancer (mRCC). Patients and Methods: We retrospectively reviewed the clinical data of patients with mRCC treated with everolimus in 2 Italian centers. Clinical evidence of SCTE was evaluated, and corresponding clinical data were reviewed for response and clinical outcome. Results: Seventy-nine mRCC patients treated with everolimus (57 male, 22 female; median age 66 years; range, 44-88 years) were evaluated. SCTE were observed in 20 (25%) of 79 patients at a median of 30.5 days of everolimus treatment (range, 10-270 days). Partial response or stable disease was achieved in 15 (79%) of 19 evaluable patients with SCTE compared to 28 (48%) of 58 with no SCTE (P = .03). At a median follow-up of 19 months, a significant difference was found in the median PFS equal to 7.8 months (95% confidence interval [CI], 2.8-24.4) in SCTE patients versus 4.3 months (95% CI, 2.7-7.5) in non-SCTE patients (P = .029), and in the median OS equal to 30.6 months (95% CI, 19.6-not reached) in SCTE patients versus 13.5 months (95% CI, 9.9-17.7) in non-SCTE patients (P = .0007). Conclusion: These data suggest that SCTE may be a predictive marker of favorable outcome in mRCC patients treated with everolimus.

KW - Dose reduction

KW - Metastatic renal-cell cancer

KW - Predictive marker

KW - Skin toxicities

KW - Survival

UR - http://www.scopus.com/inward/record.url?scp=84961797439&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=84961797439&partnerID=8YFLogxK

U2 - 10.1016/j.clgc.2016.02.012

DO - 10.1016/j.clgc.2016.02.012

M3 - Article

AN - SCOPUS:84961797439

JO - Clinical Genitourinary Cancer

JF - Clinical Genitourinary Cancer

SN - 1558-7673

ER -